Early Discharge and Outpatients Care in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia Previously Treated With Intensive Chemotherapy

July 29, 2020 updated by: Fred Hutchinson Cancer Center

Phase 2 Study of Early Discharge and Outpatient Management of Adult Patients Following Intensive Chemotherapy for MDS and Non-APL AML

This phase II trial studies how well early discharge and outpatient care works in patients with myelodysplastic syndrome or acute myeloid leukemia previously treated with intensive chemotherapy. Gathering information about patients with myelodysplastic syndrome or acute myeloid leukemia who are discharged after finishing chemotherapy, or who stay in the hospital until blood counts return to normal, may help doctors learn more about the safety of allowing patients to leave the hospital early, the patient's quality of life, use of medical services, and the cost of these services associated with such a policy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. Estimate the early death rate in patients discharged after completion of intensive induction or salvage chemotherapy.

SECONDARY OBJECTIVES:

I. Compare the costs incurred by patients discharged early after induction or salvage chemotherapy with similar patients who are discharged only after their blood counts recover.

II. Compare resource utilization (transfusions, etc.) in patients discharged early after induction or salvage chemotherapy with similar patients who are discharged only after blood count recovery.

III. Compare the quality of life in patients discharged early after induction or salvage chemotherapy with similar patients who are discharged only after their blood counts recover.

OUTLINE:

Patients are discharged within 72 hours after completion of chemotherapy and undergo standard outpatient care by a registered nurse (RN), physician assistant (PA), or resident/fellow at a local facility or the study center approximately 3 times per week, as clinically indicated for up to 45 days.

After completion of study, patients are followed up for 1 month.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) other than acute promyelocytic leukemia (APL) with t(15;17)(q22;q12), (promyelocytic leukemia [PML]/retinoic acid receptor [RAR]), or variants according to the 2008 World Health Organization (WHO) classification
  • Currently undergoing AML-like intensive induction or re-induction chemotherapy, or is planned to start such therapy within 1 week
  • Provide signed written informed consent
  • Patients can be repeatedly enrolled in this protocol (e.g. for induction and 1st or subsequent salvage therapy)

Exclusion Criteria:

  • Drug hypersensitivities or allergies disabling use of prophylactic antimicrobials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Health services research (early discharge, outpatient care)
Patients are discharged within 72 hours after completion of chemotherapy and undergo standard outpatient care by a RN, PA, or resident/fellow at a local facility or the study center approximately 3 times per week, as clinically indicated for up to 45 days.
Procedure: quality-of-life assessment
Ancillary studies
Other Names:
  • quality of life assessment
Procedure: standard follow-up care
Undergo early discharge and standard outpatient care
Other: medical chart review
Undergo early discharge and standard outpatient care
Other Names:
  • chart review

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of early deaths among patients who are discharged after completion of induction or salvage chemotherapy
Time Frame: Up to day 35
A one-sided lower exact 95% confidence interval for the proportion of early deaths after discharge will be calculated.
Up to day 35

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Investigators

  • Principal Investigator: Roland Walter, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

November 4, 2010

First Submitted That Met QC Criteria

November 4, 2010

First Posted (Estimate)

November 5, 2010

Study Record Updates

Last Update Posted (Actual)

July 31, 2020

Last Update Submitted That Met QC Criteria

July 29, 2020

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2449.00 (Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium)
  • NCI-2012-03028 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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